510(k) · Cleared
ClearedRösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Feb 15, 2018 as substantially equivalent to K955508 (Cook Urological, Inc., 1996) after a 259-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Feb 15, 2018
- Review
- 259 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955508 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK955508 Rosch -Thurmond Fallopian Tube Catheterization SetCook Urological, Inc. · 1996
- This deviceK171604 Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube…Cook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK181770 Intrauterine Access Balloon Catheter, Selective Salpingography…Cook Incorporated · 2019
Most influential descendants
Showing 1 of 1 · See all- K181770Intrauterine Access Balloon Catheter, Selective Salpingography CatheterCook Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955508 | Rosch -Thurmond Fallopian Tube Catheterization Set | Cook Urological, Inc. | 1996 | — |
| 0 (this device) | K171604 | Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube… | Cook Incorporated | 2018 | — |
| +1 | K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LKF device
- #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955508 | Rosch -Thurmond Fallopian Tube Catheterization SetSummary page 4…II Classification Panel: Obstetrics/Gynecology Predicate Device: The predicate device is the Rösch-Thurmond Fallopian Tube Catheterization Set cleared under 510(k) K955508. This predicate device has not been subject to any design related recall. Device Description: This submission contains two cathe… | 1996 |
| † | K884291 | Cook Hysterocath (TM) | 1988 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181770 | Intrauterine Access Balloon Catheter, Selective Salpingography Catheter | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K181770 (Cook Incorporated, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LKF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKF
136in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKF
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKF
95in 2025
MAUDE reports naming product code LKF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 141 | 0 | 36 |
| 2008 | 0 | — | 2 | 59 |
| 2009 | 2 | — | 0 | 53 |
| 2010 | 6 | 178 | 0 | 46 |
| 2011 | 3 | 187 | 0 | 98 |
| 2012 | 0 | — | 2 | 104 |
| 2013 | 3 | 266 | 0 | 53 |
| 2014 | 3 | 169 | 0 | 45 |
| 2015 | 5 | 140 | 0 | 53 |
| 2016 | 1 | — | 0 | 62 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 4 | 267 | 0 | 23 |
| 2019 | 1 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 0 | — | 0 | 189 |
| 2022 | 4 | 79 | 3 | 100 |
| 2023 | 0 | — | 0 | 88 |
| 2024 | 3 | 136 | 0 | 125 |
| 2025 | 2 | — | 0 | 95 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rösch Thurmond Fallopian Tube Catheterization Set is intended to be used for through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency. The Fallopian Tube Catheterization Set is intended to be used through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast…
Read the full statement (109 words)
The Rösch Thurmond Fallopian Tube Catheterization Set is intended to be used for through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency.
The Fallopian Tube Catheterization Set is intended to be used through a uterine access device for fluoroscopic selective catheterization of the proximal fallopian tube(s) and injection of contrast medium in the evaluation of tubal patency.
The Fallopian Tube Catheterization Wire Guide with Platinum Tip is to be used through a dimensionally compatible (>0.018 inch inner diameter) uterine access device or selective salpingography catheter to assist in the evaluation of tubal patency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171604: Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171604
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026